Gestational Changes in Hemodynamics and Respiratory Mechanics in Association With Pre-Eclampsia

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 50 years
• Women only
• No healthy volunteers
• Adult

Study population: Patients attending prenatal visits at Mount Sinai will be screened for eligibility by study staff.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: TREMOFLO: Gestational Changes in Hemodynamics and Respiratory Mechanics in Association With Pre-eclampsia

Conditions

Pre-eclampsia, Pregnancy, Post Partum

Medical subject headings

Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Stroke Volume

   The volume of blood pumped out of the left ventricle of the heart with each heartbeat.

   Measured: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

2. Cardiac Output

   The total volume of blood pumped out of the heart and into the rest of the body with each heartbeat.

   Measured: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

3. Systemic Vascular Resistance

   The level of force (or resistance) against which the heart must work to pump blood into the circulatory system.

   Measured: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

4. Cardiac Index

   A measure of the pumping capacity of the heart, calculated by dividing one's cardiac output by their body surface area.

   Measured: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

5. R5

   A respiratory measure of the resistance across all airways, both large and small, using 5Hz soundwaves.

   Measured: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

6. R20

   A respiratory measure of the resistance across central/large airways only, using 20Hz soundwaves.

   Measured: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

7. X5

   A respiratory measure of the elasticity of airways using 5Hz soundwaves to calculate the difference in energy to and from lung tissue.

   Measured: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

8. Fres

   This denotes the Resonant Frequency, which measures the frequency of soundwaves required to balance the internal forces of the lung tissue with its external capacity.

   Measured: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

9. AX

   Called the Area of Reactance, this is the measure of the area under the curve from the lowest measured frequency to the Resonant Frequency, and reflects the dysfunction of small airways.

   Measured: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

10. R5-R20

    A measure isolating the resistance of small airways, subtracting the R20 value from the R5 value to calculate the difference. Greater levels of this value correspond to greater small airway resistance.

    Measured: 1st Trimester at 8-14 weeks, 2nd Trimester at 22-28 weeks, 3rd Trimester at 34-40 weeks, and 4-12 Weeks Postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted10 Jul 2026
2. Study startOct 2026 (estimated)
3. Primary completionAug 2028 (estimated)
4. Study completionAug 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
• More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.